Summary of the context and overall objectives of the project

Bladder cancer is among the five most common malignancies worldwide, with more than 380,000 new cases diagnosed yearly. If detected early, the 5-year survival is high (94%), although >70% of diagnosed patients will suffer a relapse within this period. The current gold standard diagnostic tool is combined cytology and cystoscopy, which is costly and invasive, requiring transurethral access and presenting a risk of important complications. However, the high relapse rates are associated with a need for close surveillance with frequent cystoscopies, leading to an average of 13 controls per patient after the initial diagnosis. Hence, bladder cancer is one of the costliest cancers to treat and monitor.

Urologists believe that an opportunity exists to reduce the number of SURVEILLANCE cystoscopies by replacing them with a reliable, cost effective, robust and easy-to-perform non-invasive assay.

This unmet need is addressed by UROBEST, a non-invasive test that has been clinically validated in a prospective multinational study on 525 patients, demonstrating 81% sensitivity and greater than 91% specificity in discriminating cases from healthy patients at first diagnosis. These figures are comparable to those of the gold standard and notably superior to other existing molecular diagnostic products.

During phase I of the SME instrument, Fina Biotech has acquired a deeper understanding of the market and with the assistance of key opinion leaders it has designed a clinical study that will support the positioning our test in the most attractive market segment. We have also clarified the intellectual property situation of our product, Fina Biotech having filed European and PCT patent applications protecting the invention in 2013. Because of these studies, we have redefined our business model from that of a research and out-licensing organization, to that of a production and sales company.

Indeed, we estimate the current market for bladder cancer biomarker based tests to be above €200 million.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The main results of UROBEST are described in a detailed business plan. Phase I of the UROBEST project has led to a redefinition of our business plan. We conclude that it is feasible to develop, manufacture and market UROBEST. A new company - Biofina Diagnostics - has been set up to carry out the mission of taking UROBEST to the market. This new business plan has a greater level of ambition as it will integrate vertically along the value chain. We will transform a small R&D focused organization into a manufacturing and marketing organization capturing more added value. In addition, new product development opportunities have been identified that will lead to improved versions of UROBEST. The expected result of the UROBEST project is a non-invasive tool for monitoring bladder cancer patients that will result in:• Improved quality of life for patients who will see a reduction in unnecessary invasive cystoscopies.• Reduced workloads for urologists.• Cost reductions for healthcare providers due to the replacement of costlier cystoscopies with a biomarker-based assay and to a reduction in the incidence of their iatrogenic effects.